The multicenter, open-label phase II study enrolled 71 advanced/metastatic IHC patients with FGFR2 fusions who progressed on or are intolerant to platinum-based chemotherapy. Results showed that the overall response rate (ORR) was 31.5% (95% CI, 20.5%-43.1%). Among patients who had receive one or fewer previous treatments, the ORR was 39.3%, whereas patients who had received two or more prior treatments had an ORR of 17.9%. In addition, median progression-free survival and overall survival was 6.8 months (95% CI, 5.8-7.6) and 12.5 months (9.9-16.6), respectively. These results show that infigratinib has strong potential to be a new treatment option for IHC patients. A new phase 3 study has been initiated comparing infigratinib to standard of care chemotherapy for first line IHC treatment.
Source : Javle M, Kelley RK, Roychowdhury S, et al. In: Proceedings from the 2018 ESMO Congress; October 19-23, 2018; Munich, Germany. Abstract 3652.